“Traditionally, the word ‘decontamination’ has been applied to those cleaning procedures—automatic and/or manual—that take place prior to sterilisation. Recent documentation, however, has redefined the word to apply to the whole series of procedures to ensure that a device is made safe after use on one patient prior to use on a second. Decontamination can thus include cleaning, disinfecting and sterilising.” This statement is taken from an article published in the ISSM (Institute of Sterile Service Managers) Journal, Vol. 5, No. 1 July-September 2000. The statement helps to explain what the decontamination process has come to mean in modern UK hospitals and goes on to refer to HTM2030, which has been the driver for change in processing many types of medical instruments. The term ‘decontamination’ will be used herein to refer to the above redefinition, including cleaning and disinfecting.
Health Technical Memorandum (HTM) 2030 was introduced in 1993 and updated in 1997 and 2001 to improve the sterile processing performance of washer disinfectors. HTM2030 addresses the use of washer-disinfectors for instruments, many of which cannot be autoclaved, for example flexible endoscopes. In essence, it describes the need to wash instruments thoroughly before disinfection/sterilisation (by heat or by chemical); to be followed by the disinfection/sterilisation stage and to culminate, in the case of chemical disinfection, in the rinsing of the instrument. HTM2030 also addresses the need for the entire process to be recorded in a traceability and audit system.
Two-part disinfecting solutions are used in applications where the active disinfecting ingredient is unstable over time. The solution is therefore prepared in situ shortly before it is to be used. A particularly important disinfecting agent is chlorine dioxide (ClO2) which may be formed from mixtures of various reagents including: chlorite and acid; chlorate, peroxide and acid; and chlorite, hypochlorite, and a suitable buffer. Chlorine dioxide has excellent disinfecting and bactericidal properties, and oral ingestion in man and animals has been shown to be relatively safe.
It is not always convenient to mix up batches of solutions for use in disinfecting equipment. For wiping down (rather than thoroughly cleaning inside and out) of endoscopes and probes, wipes of alcohol, general-purpose detergent, or soapy water are generally used, but these are not as effective as chlorine dioxide. It is desirable to be able readily to make up small quantities of two-component disinfecting agents when desired and to be able to make such agents up in a form in which they may be readily handled for a particular application. It is particularly desired to provide a decontamination system which meets the HTM2030 standard.
The decontamination of endoscopes and other medical equipment to HTM2030 standard with chlorine dioxide or other suitable two-part disinfectant solutions is known. See, for example, EP 1 742 672 and U.S. Pat. No. 7,807,118, which disclose a system comprising a plurality of pre-clean wipes, a two-part disinfectant system of reagents that react when combined to provide a disinfecting composition in a fabric member, and a plurality of rinse wipes. A operator cleans an instrument with a pre-clean wipe to remove gross contamination, then disinfects the external surfaces using the freshly-prepared disinfectant wipe, and removes or neutralises the disinfectant with a rinse wipe. The system can include removable adhesive labels associated with each disinfecting wipe, which provide information about an item such as the lot or batch number, date of manufacture, or a use-by or expiry date. The adhesive labels are affixed to a space in a record sheet for recording details about the decontamination of a particular instrument, and the record sheet provides space for recordal of details such as whether the instrument is to be returned to a specific patient or to storage, and confirmation that the system components have been used in the correct order. The system aids the provision of a quality audit trail for a decontaminated medical instrument.